Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine

Aesculap AG200 enrolled

Overview

Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. Previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. Thus, it is not surprising that there is a limited amount of published literature available describing the use of the Uni-Graft® K DV Patch in the clinical routine. Therefore, the aim of the present non-interventional study (NIS) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the Uni-Graft® K DV Patch.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Femoral Artery Stenosis Iliac Artery Stenosis Carotid Artery Stenosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥ 18 years * written informed consent * treated with Uni-Graft® K DV Patch for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery Exclusion Criteria: * Use of the Uni-Graft® K DV Patch if allergies to components of the patch are known * Use of the Uni-Graft® K DV Patch in case of a known hypersensitive reaction to the patch and / or its components (e.g. polyethylene terephthalate). * No use of Uni-Graft® K DV Patch * Use of Uni-Graft® K DV Patch outside the intended use of the product at the date of application

Outcomes

Primary Outcomes

Restenosis Rate in postoperative Course

Retrospective evaluation of restenosis rate from information documented in the patient file: the NASCET is an angiographic measurement recommended by the "North American Symptomatic Carotid Endarterectomy Trial"-Group. According to the NASCET-Method the grade of stenosis in relation to the diameter of the ACI distal to the stenosis in the area of the parallel arterial wall is measured.